Abstract

The pharmacovigilance aims at detecting adverse effects of marketed drugs. It is based on the spontaneous reporting of events that are supposed to be adverse effects of drugs. The Spontaneous Reporting System (SRS) is supplying huge databases that pharmacovigilance experts cannot exhaustively exploit without any data mining tools. Data mining methods have been proposed in the literature but none of them is the object of a consensus in terms of applicability and efficiency. It is especially due to the difficulties to evaluate the methods on real data. In this context, the aim of this paper is to propose the SRS modelling in order to simulate realistic data that would permit to complete the methods evaluation and comparison, with the perspective to help in defining surveillance strategies. In fact, as the status of the drug-event relations is known in the simulated dataset, the signal generated by the data mining methods can be labelled as ”true ” or ”false”. Spontaneous Reporting process is viewed as a Poisson process depending on the drugs exposure frequency, on the delay from the drugs launch, on the adverse events background incidence and seriousness and on a reporting probability. This reporting probability, quantitatively unknown, is derived from the qualitative knowledge found in literature and expressed by experts. This knowledge is represented and exploited by means of a fuzzy characterisation of variables and a set of fuzzy rules. Simulated data are described and two Bayesian data mining methods are applied to illustrate the kind of information, on methods performances, that can be derived from the SRS modelling and from the data simulation. 1

Citations